DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE
Journal Title: International Journal of Drug Regulatory Affairs - Year 2015, Vol 3, Issue 2
Abstract
In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality, safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuring safety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms. The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to the fulfilment of the needs of the less privileged rural population. Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at an annual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market is highly dependent on imports, which account for around 75% of the total pharmaceutical market. The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up by the TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally
Authors and Affiliations
Jain Achin, Venkatesh M P, Pramod Kumar T M
Keywords
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